Johnson & Johnson, the manufacturer of the antipsychotic drug Risperdal, has reached an agreement to settle five lawsuits over claims that it causes boys who were prescribed Risperdal, to grow breast-tissues.
Risperdal was first introduced in 1994, and is a drug that earned J&J billions of dollars in sales before generic forms became available years ago. It has been connected to increased risk of strokes, seizures, weight gain and diabetes while it is used off-label to treat dementia, bipolar disorders, schizophrenia, and irritability in autism patients. J&J has denied any offense or misconduct on the basis that the U.S. Food and Drug Administration gave its approval in 1993 to Risperdal for psychotic disorders, and that it was approved later for other uses. J&J also argues that boys' breast growth was normal for teens going through puberty, and that the drug played no role in it.
However, the FDA gave no approval for use in children until 2006. "Since the early 1990s, Risperdal has improved the lives of countless people throughout the world who suffer from the devastating effects of serious mental illness," said a spokeswoman. Johnson & Johnson essentially concealed the fact that Risperdal could increase hormone levels that stimulated breast development in males. Andrew Bentley, a 17-year old resident of Texas, claims that he grew breasts after taking Risperdal to treat conditions related to Asperger's Syndrome at a time when the FDA had not approved the drug for children.
Bentley's litigation is among the many lawsuits against Johnson & Johnson by plaintiffs who claim injury from Risperdal. As stated in Bloomberg News, there are currently more than 400 individual Risperdal lawsuits pending around the country and more than one hundred involving personal injuries and claims that the drug caused young males to grow breasts. Although these appeals are unresolved, the company has already lost cases in Louisiana, South Carolina and Arkansas in which it was claimed to have endorsed this drug inappropriately through "taxpayer-funded Medicaid systems." Johnson & Johnson has agreed to pay $181 million to resolve similar litigation involving the improper marketing of antipsychotic drugs Risperdal and Invega with a total of thirty-six states, and is also negotiating with the federal government on a case the company might pay more than $2 billion on.
J&J is currently dealing with legal action over illegal marketing of Risperdal, not only in federal but in a number of state courts as well. Furthermore, the company faces countless lawsuits over wrongly marketing and promoting medical devices that they knew were unsafe for many individuals.